SJ4 Post Approval Study in Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Defibrillator Patients

The purpose of this study is to characterize the chronic performance of the St. Jude Medical SJ4 connector and RV high voltage SJ4 leads.

Completed

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Key information

Conditions

Tachyarrhythmias Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Sudden Cardiac Death Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Have an approved indication per ACC/AHA/HRS guidelines for implantation of heart failure or life-threatening ventricular tachyarrhythmias and will be implanted with a St. Jude Medical SJ4 system.
Have the ability to provide informed consent for study participating and be willing and able to comply with the prescribed follow-up test and schedule of evaluations.

Exclusion criteria

Be currently participating in a clinical investigation that includes an active treatment arm.
Have a life expectancy of less than 6 months due to any condition.
Be less than 18 years of age.

Treatment and study plan

SJ4 connector and RV high voltage SJ4 lead

Device

Standard of care implantation of SJ4 device system

Primary outcomes

Right Ventricle (RV) Bipolar Capture Thresholds

Time frame: 5 years
Complication Free Survival Rate Related to the High Voltage RV SJ4 Lead or SJ4 Connector

Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

SJ4 Post Approval Study

Important dates

Study start: 2009
Primary completion: 2015
Study completion: 2015
First posted: Jul 16, 2009
Registry last updated: Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed